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Investor Day 2023

Oct 3, 2023

Elizabeth Kennard
VP of Global Marketing, Accuray

Welcome to Accuray's Investor Briefing Meeting at ASTRO. My name is Elizabeth Kennard, and I'm the Vice President of Global Marketing here at Accuray. Joining us today, we have Suzanne Winter, our Chief Executive Officer, Ali Pervaiz, Chief Financial Officer, Sandeep Chalke, Chief Commercial Officer, Dr. Seth Blacksburg, our Chief Medical Officer, and Awais Mirza, our Director of Patient Access. We're also joined by our esteemed guests and global thought leaders, Dr. Sean Collins, Dr. Jon Lischalk, Dr. Nima Aghdam, and Dr. Connie Mantz. Thank you for joining us. During the meeting, you will hear from Accuray leadership team, who will highlight the company's vision for advancing patient care while creating value for our stakeholders.

You will also have the opportunity to hear from our guests on multiple topics, including their perspectives on Accuray technology, the future of radiation medicine and trends, and alternative payment models in radiation oncology. We will hold a Q&A session immediately following the presentations. All of our remote attendees will be muted during the meeting. You may submit your questions during the presentations via the Ask a Question box located on the webcast page, or ask them live if you are here in person. We request that you hold all questions related to our fiscal first quarter, ended September 30, 2023. We will host a separate earnings call to report the results of our fiscal first quarter on Wednesday, November 1, after the close of the market.

Before we begin, I would like to remind you that our presentation today includes forward-looking statements, including statements related to our product roadmap, growth, and growth catalysts. Actual results may differ materially from those contemplated by these forward-looking statements. Factors that could cause these results to differ materially are set forth in the slides accompanying today's presentation, as well as in our filings with the SEC. These forward-looking statements are based on information available to us and the management's expectations as of today's date, and we assume no obligation to update any forward-looking statements as a result of new information or future events. With that, let me turn the meeting over to Accuray's Chief Executive Officer, Suzanne Winter. Suzanne?

Suzanne Winter
CEO, Accuray

Thank you, Elizabeth. Thank you, and welcome to all the participants that are joining us here at the American Society of Radiation Oncology in San Diego and those that are joining us virtually. As Elizabeth went through, we have a very rich agenda. I won't go through it again, but we'll cover a variety of topics. I'm going to start out with just the business overview and then we have a whole section on real-world experience from our esteemed clinician panel, who will be talking about their experience and clinical trends that they're seeing in radiation oncology. Let me start out by just our overall vision here at Accuray.

You know, very simply, we want to conquer cancer, and we want to do that by really advancing technology and our solutions, you know, to extend lives and to advance the technology to the point that it is curative. We also want to reduce the overall burden for patients. This is a terrible disease. It's terrible for the families, and to the extent that we can provide solutions to be able to reduce that burden, shorter sessions, the SBRT that we're going to be talking about as a clinical technique, but also the ability to then improve the quality of lives, and we do that through highly precise, targeted treatments. Everyone at our company has had some experience, either in their family or themselves, that have had an experience with cancer.

It's, you know, it's a very stressful time in our patients' lives. Everyone that works at our company is really driven by a higher mission, and it is something that has allowed us to attract outstanding talent because we're doing good things, and it's nice to be able to have a higher purpose to what we do on a daily basis. We have an outstanding executive team, many of whom are joining us here in the room. But all of these folks have just a wealth of healthcare experience at large companies, at clinical institutions. Some are radiation oncologists, but all of them have come to the company because they believe in the technology and what Accuray is trying to accomplish. So we're incredibly proud to have them on board.

Very important to know that all of our incentives at the executive level are also aligned with what our shareholders also value. So not only are we incented on revenue, but also EBITDA and profitability overall. We have a tremendous board of directors with extensive med tech experience, former CFOs, chief marketing officers, operational VPs, that come to us and provide guidance for us as a management team. This is a working board. We have a great, I think, working relationship and governance. So, you know, we're all focused on value creation for our stakeholders. You know, just again, at the very highest level, you know, cancer continues to be a leading cause of death, and cancer incidence continues to grow.

I think by 2030, 20 million people annually will have been diagnosed with cancer. At the same time, 10 million will die as a result of cancer. And so there's a tremendous need to close the gaps. There's also global disparity in the access to care and access to radiation therapy. You know, just from a radiation therapy landscape, you know, the global market is really dominated by three companies. They're very high barriers to entry. The infrastructure that is required to be able to support our products and our customers is very steep, and there's a significant, significant capital investment for our customers to buy radiation therapy, not only at the initial purchase, but on an ongoing basis....

These are just dynamics for the landscape, but I think it's important to understand that you have to be good as a radiation therapy company in supporting every aspect of the investment. Installed base, IB growth is a critical success factor, I think, to your long-term future. Not only do we need to, of course, get orders for new equipment, but we need to get them in the ground, installed, and in use, and that's a key to growth. If we look at the markets, they're really at the highest level in two dimensions. One are the developed markets like the U.S., Western Europe, Japan, which is largely a replacement market, that at this point, it's—you're either growing by stealing competitive share and also protecting your own installed base.

In the emerging markets, it's the opposite. This is where radiation therapy is under-penetrated, and really, the growth comes from the installation of new radiation therapy vaults. So at the highest level, you know, Accuray, our goal is really to close the gaps to cancer care, and really in three dimensions. We want to continue to invest in R&D and innovation so that we are closing the gaps to the real pain points in radiation therapy and providing solutions not only from a technology, but also service and support. Driving patient access to radiotherapy treatments, again, this is still a gap, not only in the developed markets, in rural areas, but in what we are going to target as the high-potential, underserved, emerging market areas.

Then finally, very critical to our success, but just as important as the former two, are delighting our customers. Once they've made this investment, this is a long-term investment. It's critically important that we maintain high operational performance so that no patient is rescheduled. That's how we want to measure ourselves, is not necessarily on system uptime, but really if a patient has had to be rescheduled, and have their treatment rescheduled. Our strategic growth plan is really in four players. One, we want to continue to outpace the market through growth, and innovations and capture share. Second, we think the service business has a tremendous opportunity for Accuray, so expanding the service revenue, not only through installed base growth and a focus on uptime, but also new services and solutions that we can sell back into our installed base.

We are continuously looking, and you're going to hear from Ali Pervaiz about operational excellence and efficiency, looking for opportunities to streamline our business, to operate more effectively, so that we are running with the, the utmost efficiency. And then finally, profitability expansion. Very important to our business and strengthening our balance sheet and cash flow so that we maintain our flexibility to do strategic things into the future. Accuray has a, has a history of innovation-driven growth, and it's really been in our DNA back from the introduction of the CyberKnife, and to the acquisition of TomoTherapy, in 2012, as well as to where we are now today, where we have had a number of new innovations onto our platforms. The CyberKnife S7, most recently, the Radixact ClearRT.

We have introduced Volo Ultra, Synchrony on Radixact, and now with our latest VitalHold, breast, comprehensive breast package. And we are continuing to invest and looking at those clinical issues that are still barriers to providing the best therapy available. Just a little bit, you know, we have two major platforms. Both of them are highly differentiated. The Radixact system, as you can see on the video, is a helical system. It's helical imaging, and is a full CT on the system and continuously delivers radiation therapy in a helical fashion. It is the ultimate full-body workhorse solution that is able to do a versatile array of applications. The CyberKnife system, very different. First robotic system. You can see the patient does not go into a bore, so there's no claustrophobia. The...

It's actually a robotic arm with a linear accelerator at the end. It actually moves around the patients. It's a phenomenal system that can provide whole-body stereotactic radiosurgery and SBRT. We really pioneered with the CyberKnife the use of hypofractionation, and so the CyberKnife continues to be a very strong product in the marketplace. Highlights from ASTRO. So we are showing a number of different things. We are again continuing to show our ClearRT, high-quality CT imaging on the Radixact system. This has been just a tremendous growth catalyst for our business and driving new Radixact system sales. VitalHold is as a result of our partnership with C-RAD. This is a surface-guided radiation therapy that really allows us now in the U.S. and in Europe to take orders and ship and it provides a comprehensive breast solution.

We should be getting shown in here in the fall in preparation for JASTRO as well. We are showing here on the show some additional value-added service solutions, enhanced education, and enhanced physics support through our Alliance A+ offering, and we are also introducing Accuray Financial Services. This is a partnership that we are doing to provide additional flexibility in financing solutions for our customers that are having challenges with access to capital. And then finally, we introduced here as a 510(k) pending the online adaptive solution for Radixact called Cenos. We have had tremendous response to Cenos, and this adds to our tool set in adaptive therapy. We have an offline adaptive toolkit.

We have Synchrony that provides real-time motion compensation and adaptation, and now we have an online with the patient, on the table, ability to take a look at treatment planning to see if any adjustments need to be made. So something that we do interfraction as well as intrafraction, we are now able, really to provide a full tool set for clinicians to take a look at patient and tailor the delivery based on how they're presenting. We have this. We've done this in partnership with Limbus AI, so it's another powerful product of partnerships within the industry. You know, just at the highest level, from the highlights, we're tremendously proud to have surpassed our 1,000 installed base milestone.

This is incredibly important, just showing the importance of first of all, global adoption of the technology, but also gives us a critical mass to be able to support these customers. You know, in FY 2023, we had the highest total revenue that we've had in the history of the company. Within that, we had 9% year-over-year product revenue growth, which is tremendous, just again showing above-market growth in system adoption. You know, we also were able to ship out the highest number of systems from our factory at 24% growth overall in unit volume. This really speaks so much to our company's ability to really face a lot of supply chain headwinds that we encountered this past year. So very proud of our teams, and their resiliency in the face of those headwinds.

Again, we grew our global installed base 5% year over year, very important for our service revenue growth, and we were included in the Russell Index, which again, very important to us as a stock to get that visibility within the marketplace. Then finally, we announced a new headquarters location. So we changed our headquarters location from Sunnyvale, California, to Madison, Wisconsin. We did it for a number of strategic reasons, one of which is we certainly get a lot more visibility from a government standpoint by being one of few in Wisconsin versus one of many in California. But we also have some operational savings moving from California to Wisconsin, which, you know, Ali will talk more detail about. But we have growing global momentum. We're excited about what we are seeing.

It speaks to the momentum we're seeing in the marketplace, but also the adoption of our new product innovation. We talked about, you know, our installed base growth, which is higher than our CAGR for the last five years. Same thing with unit volume growth. You know, we are seeing growing momentum now. Very important to us that we have balanced regional revenue contribution, that we're not relying on any one region. We have four regions: the Americas, the European and Middle East, Africa and India, our APAC, which includes China and also Japan. You know, we think there's significant market opportunity for Accuray. We have been primarily competing on the left-hand side of this slide, which is in a $1.75 billion part of a $3.5 billion market, which has been mainly in the premium and specialty markets.

You know, that we foresee low growth in this segment of the market, and our estimated share is around 26%. Really, the opportunity for us is now to compete in these emerging market locations where they may not be able to buy premium systems, and that would be the value segment part of the market. We're not interested in competing in the economy market, that's a highly price-sensitive segment of the market, but the value market is open to us, and that also has the greatest growth globally at 8%-10% growth. And we are expanding with new products into this value segment, the Tomo C, which is our jointly developed product that is manufactured in Tianjin, China, to fuel our growth in the Type B value segment part of the market.

We released today at 1:00 P.M., a press release that announced that we did get NMPA approval for the Tomo C. So we're excited about that. And that will allow our joint venture team in the field to start taking orders from customers. We're still waiting on the treatment planning section to be able to ship to customers, but this is a major milestone for us, so we're excited about the potential.

We are also going to be introducing a value segment product called the Accuray Helix, that will be for other non-China value segment parts of the market. We are going to start out with an introduction in November in Mumbai, for the India market, and we're excited about the potential for this as well. That will be manufactured in Madison, Wisconsin. With that, I'm going to hand it over to Sandeep Chalke, who's going to talk through our commercial strategy.

Sandeep Chalke
Chief Commercial Officer, Accuray

Thank you, Suzanne. Let me see. All right, I'll take you through some of the commercial strategies here. We operate about seventy in 60 different countries today, and like Suzanne said, we are already taking the region, doubling down into different regions in different countries, and also taking opening up new countries at the same time. So we're growing every quarter from one country, one region, to new countries and new regions as well. We talked about the four different regions that we have together, and the priorities, again, the high-level priorities that we set for ourselves, are based on few high-level areas. 42% of our revenue today is recurring revenue, comes out of the installed base only. So that means dependent on service contract revenue and associated dollars which are attached to it. Within that, we have different strategies by region.

In the AMS or U.S. market, we have a protect strategy, and then similarly in Japan, which is a mature market, we are protecting our installed base and taking on some of the competitive installed base over. In Europe and in APAC, including China, is where we see new bunkers or new walls getting built, and the access is growing on a daily basis, on a quarterly basis, and we are tapping into that installed base growth. Market growth is where we see different dynamics between regions as well. The recessionary pressure, the access to capital that Suzanne just talked about on the U.S. side is seen, is felt, and we are creating different solutions, including financing.

But in the European market, Indian market, Middle East, Africa, and also in Asia Pacific, including China, we see growth in the market itself, and we are prepared to take on such growth by way of segmentation, customer segmentation, product mix, as well as financing. And on the channel basis, basically, we are mostly indirect company, but we have some really strong presence in a few countries with a direct market or direct presence, where we sell direct and we service direct. And we are tapping onto more countries as we speak, as we see more potential to grow. And whenever we see the potential and the growth coming in, we are also moving from indirect to direct business as well. So that's a high-level piece a little bit. Let me double down into three different areas on giving you some details. We talked about China.

China, as you have seen already, that we have been gaining momentum on growing installed base on a double-digit CAGR for last couple of years, last few years, and we have a significant share in the Type A market. The Tomo C product essentially gives us access to the Type B market, which is yet another or probably the largest market available in China. And for NMPA's an announcement just came in today, but we've been working in that market, doing roadshows and attending events for starting earlier this year already. So we are prepping the market, and the reception for this first helical delivery, locally available product has been phenomenal. So we expect a good momentum to build from here as we start taking orders starting next month, or rather in October itself. So we'll start building that momentum and see more growth coming from China.

We talked about a little bit about partnerships and some of the real examples that you see at the ASTRO. Some of you have actually walked the floor. Cenos, we just talked about, and Limbus AI is where we partner with. It gives us access in the AI technology as well. C-RAD is our partner for the comprehensive breast package that we just that we are, we have FDA clearance and also CE Mark clearance, and we are waiting to enter in Japan. GE Healthcare essentially gives us the commercial partnership access and builds that partnership to take on the commercial solution. And then Brainlab is like, you know, we, we have the neuro access with Brainlab, and RaySearch has been our long-term partner already, and we, we continue to grow with them.

We're not stopping just at the core partnership for our product or technology, but also looking at partnering with QA suppliers, quality assurance suppliers, and also commercial partnership. Essentially, when we look at partnership, it generates speed for us. It keeps us relevant, it keeps us significantly involved, and make it current offerings. For our customers, it essentially gives us a lot of flexibility, along with best-in-class solution as the customers look at us for better solutions overall. The next slide, I'll just show you a quick example of what it takes when we say a Radixact-like equipment gets installed. And this is a time-lapsed video, one of our recent installation in Switzerland, where a large Radixact equipment is getting built.

We have a bunker, which is about four-foot poured concrete bunker, which goes on all four walls, ceiling, and flooring. It takes a lot of many, many resources to build an installation and build the unit in. Then we calibrate the equipment before we handing over. So it takes about six to eight weeks, sometimes nine weeks, depending on the site requirements and how the infrastructure is built around that in that hospital. We talked about service. Suzanne did touch on the service is our growth opportunity, and we believe it is something which we're just starting. But just before I did that, let me just take you through the life cycle of this. This is a long life cycle business.

We take orders, and when we-- From orders to shipment, it takes about 18 months to 24 months before we start shipping. That's when we clock the revenue. Then we talked about the install and go live. It takes about three months. We then have 12 months of warranty, and then about 10 years or so, we have to support our customer through service contract. And at the end, back end of it, about three to five years, sometimes our customers do extend the life of this equipment. So there are different life cycles that we have to go through, and at the same time, the revenue that we generate from every single equipment, it comes in stages.

It comes at the time of point of shipment, it comes at point of installation, warranty, and then number of service contract, which is an annuity business for us as we go from one year to the other, and the back end is something similar. Now, when we say we want to grow the service revenue, we're not dependent only on the service contract revenue here. We're trying to expand the experience of our customers by enhancing the offerings. We talked about the Alliance A+.

These are the new offerings which are coming together and will be bundled and given to our customers throughout the life cycle of the of the equipment itself. So that's the service contract or, or the high levels of overall growth that we are looking at from at Accuray, and we are very proud to take this business to the next level. I would like to introduce Seth, Dr. Seth Blacksburg, as our CMO, for taking out from the clinical radiation. Thank you.

Seth Blacksburg
Chief Medical Officer, Accuray

Thank you so much. So in terms of clinical trends in radiation therapy growth, it is an exciting time to be a radiation oncologist. What we are seeing is the confluence of different technologies that are allowing us to treat patients better. We're seeing improvements in diagnostic radiology. We're seeing improvements in genomic assays. We're seeing improvements in our ability to detect disease at different stages. And so we're able to offer incredible technology to improve quality of life and duration of life to millions of folks worldwide. And when we think about the spectrum of disease, what we're seeing is an ability to detect disease at its extremes. We're able to detect cancer at much earlier stages, where technologies that Accuray has can be utilized to cure folks very early on. And so we're detecting early-stage cancers much earlier. We're also seeing that we can detect cancers much later.

We're seeing patients who have metastatic disease, where we can offer them ablative therapies to improve their quality and duration of life. So it is an extremely exciting time. During this confluence of technologies, we're also seeing improvements in systemic therapies like immunotherapies. So patients are living longer, and as a result of living longer, they may manifest cancers later on during their course of life, and radiation therapy has been proven to be extremely effective at helping those patients. And when we looked at trends in radiation oncology over the next five to 10 years, what we see overall is projected trends where we're expected to grow as a field.

But when we go into the data a little bit more, what we see is there are areas of radiation that are expected to contract, and those are older forms of delivering treatment, conventional radiotherapy or seeds or brachytherapy, where you actually place radioactive sources inside of the body. Those are expected to decline. Proton therapy is expected to decline. Areas where radiation is projected to grow, and when even at proceedings like ASTRO, we are seeing the buzz and the excitement, is in the ability to deliver radiation that's been shaped and is precisely delivered. One form of that is intensity-modulated radiotherapy, which is computer-guided radiation, where you could shape the doses to really aim at the tumor and spare the normal tissues, and the other is in stereotactic applications. Overall, the field of radiation oncology is moving towards fewer treatments.

Along the spectrum of many treatments to just a single treatment, sort of the trend is in hypofractionation, which is fewer number of treatments, and the end of that is called stereotactic radiotherapy, where you could deliver ablative doses in between one and five fractions. We believe, with a lot of what we've already seen, that Accuray technology is extremely well-positioned to provide advantages in this area and capitalize on these trends. When we look at clinical trends overall, what we're seeing is a focus on personalized medicine. So being able to tailor specifically to an individual's cancer diagnosis and their own biology, a treatment that will be best for them, is something that is extremely popular in oncology, but it needs to be firmly tethered to workflow and economic realities.

We have a treat for all of us, where we have four widely respected thought leaders who are going to talk with us today. Three areas where we are seeing, and ASTRO is showing this, tremendous growth in the field of radiation medicine is in prostate stereotactic radiotherapy, in the use of radiation to treat oligometastatic disease, and the use of radiation to treat CNS, central nervous system disease. I'm going to go through it quickly because our thought leaders will shed a little bit more light on that. Prostate stereotactic body radiotherapy refers to using five or fewer treatments to treat prostate cancer for cure.

What we've seen here at the proceedings of ASTRO is in the plenary session, Professor Nick van As from The Royal Marsden presented five-year data showing an excellent outcome on delivering fewer number of treatments for patients who have prostate cancer. Accuray has sponsored data where we have mature ten-year outcomes demonstrating this excellent treatment is available for folks, and Dr. Sean Collins is going to go more into that space. Oligometastatic disease is an extremely exciting area. Traditionally, radiation oncologists have been trained to think of cancer as either being curative or palliative, and that paradigm has changed dramatically over the last five to seven years, where we're now thinking of cases where there's metastatic disease as something that could be treated, where the patient will die with, rather than from that cancer.

That's known as oligometastatic disease, which is a disease state where we can provide stereotactic ablative treatments to select areas of the body and let somebody live much longer and with less toxicity. We're seeing an explosion in the field of radiation in this field and just cancer in general. Dr. Jon Lischalk is going to talk to us a lot more about that. Certainly, with advances in diagnostic imaging and in systemic agents, this is growing by leaps and bounds. Finally, central nervous system, so brain and spine tumors, where we are seeing a growth in the utilization, the adoption, and excitement over applying stereotactic radiotherapies to address both malignant lesions and benign lesions.

So as we start changing our philosophy on cancer care, the focus is on treating less normal tissues of the body, and this is where stereotactic ablative therapies, such as the ones Accuray provides and is exceptional at, is becoming more and more popular. Dr. Nima Aghdam will go over that. We support our providers and clinicians with outstanding education. We think this is a pillar of oncology care, and we have global training hubs that are being set up and that have been set up in China, Japan, in Wisconsin, and Switzerland, where we have advanced curricula, where we're allowing clinicians to develop confidence in utilizing our technology and help develop with them better ways of treating advanced cancers and early-stage cancers.

And then, what we're finding is that by addressing clinicians hands-on, we're seeing direct benefits to reaching out to folks and training them and learning from them. These are two examples on the international stage, where we've had symposia and hands-on applications in Tokyo and in Barranquilla, Colombia, which has been met with extreme enthusiasm and even machine sales. And so it's now my pleasure to introduce some, as I mentioned, widely respected thought leaders. Who we have today is Dr. Sean Collins, who's a professor at Georgetown University. He's going to be giving a lecture on prostate stereotactic body radiation therapy.

Dr. Jon Lischalk from NYU, who is gonna talk with us about oligometastatic disease, and Dr. Nima Aghdam from the Harvard Medical School at Beth Israel Deaconess Medical Center, who will talk to us about central nervous system treatment. And so I'm going to introduce Dr. Sean Collins and welcome him here. So Dr. Collins is the director of the CyberKnife Prostate Program at MedStar Georgetown University Hospital, and a professor of radiation medicine at Georgetown University School of Medicine.

Dr. Collins joined Georgetown in 2006 after completing his residency in radiation oncology at MedStar Georgetown and the Lombardi Comprehensive Cancer Center, and previously, a surgical internship at the hospital. In addition to his medical degree, Dr. Collins holds a doctorate in biological chemistry from the University of Michigan's Medical Scientists Training Program. He has published extensively on outcomes and quality of life as it relates to prostate stereotactic body radiation, and he's a frequent international lecturer.

He serves as a reviewer and editorial board member for numerous medicine and oncology journals, and he has amongst the highest volume of prostate stereotactic radiotherapy manuscripts that have been published internationally to date. He is a frequent lecturer on domestic and international stage and is widely recognized as one of the leading authorities on the use of stereotactic radiation therapy for treating prostate cancer. We're absolutely elated to have him join us today. Thank you, Sean.

Sean Collins
Director of CyberKnife Prostate Program, MedStar Georgetown University Hospital

So I want to say that, I've treated 2,300 patients with the CyberKnife for prostate cancer, and the best thing that Accuray has done this year is gotten Seth Blacksburg as your Chief Medical Officer. When I have a question about... If I have a challenging case in prostate SBRT, what I do is I call up Seth because he genuinely cares about the patient being treated correctly, and I thank him every time for being my friend and helping me with challenging cases. So the future of prostate radiation oncology, in my opinion, involves both the CyberKnife and Radixact, and I'm going to try to explain that to you today, why I feel that way. I am an Accuray clinical consultant.

I do have some disclosures, and this slide right here is called The Inconvenient Truth of Prostate Radiation Oncology. So Michael Zelefsky is one of the best prostate radiation oncologists in the world, and when I was a resident, 15, over 15 years ago, this was the data that came out using conventionally fractionated radiation. And unfortunately, when you treat. We do well with low-risk prostate cancer. We cure 95% of patients. Unfortunately, with. We didn't do very well with intermediate and high-risk prostate cancer, even if you were at Memorial Sloan Kettering and getting treated by Michael Zelefsky. And what was the reason for this? Your prostate actually moves. So for the guys in the audience, your prostate's probably moving right now.

In the past, we never adjusted the radiation beam, not until we had a CyberKnife and Accuray did a great job of building the technology that we actually track the prostate. Also, the radiation dose was inadequate because we all know that the bladder, the rectum, and your penis are right next to your prostate, and if you give a high dose to those areas, you can injure them. So you need really precise radiation that you have faith in if you're going to treat higher doses. And because I had a CyberKnife 17 years ago, I felt that I had the precision to treat men with five fractions of prostate cancer.

The thing is that we found out today, I mean, I felt kind of good this week, because after doing this for 17 years, we have our report of the PACE Trial saying there is no difference between five fractions and 40 fractions of radiation. There is absolutely no reason to go for 40 fractions of radiation anymore. I feel 100% comfortable that I am giving a great treatment with five large doses of radiation, even though the prostate moves. As many important people have shown, prostate motion, you need to take it into track. Accuray has the best physicists and the best engineers in the world, in my opinion, and they have taught me how to use gold markers to track the prostate and adjust for six degrees of motion.

Because we're adjusting for all six degrees of motion, we feel really comfortable that we can treat with really tight margins, and we're not missing the tumor when we're treating. We also can take rotation to account, which most other radiation machines cannot take rotations into account. Rotations are really important. Your prostate rotates on the apex, and if you don't take rotations into account, you miss the target. Now, movement of the prostate can happen both continuously or you can have large movements in the prostate. Because the CyberKnife is imaging consistently every minute or so, if you have a large motion, you will know about it and you will adjust for it, and you will do continuous tracking that's, in my opinion, absolutely required for giving a highly effective five-fraction regimen for prostate cancer.

You can treat with smaller margins, and you can have less toxicity to the bladder, less toxicity to the rectum. These are the important things if you're a 70-year-old guy living your life and, making sure that you can have time to spend with your children, go out and travel the world. You don't want to be urinating on yourself or having frequent bowel movements. And I feel that I have complete faith that with the CyberKnife, I'm not gonna cause these elderly gentlemen to ruin their retirements. Because we have such accuracy, we can use small treatment margins. Small treatment margins reduce toxicity. Don't let anybody else out there say that they can treat with smaller treatment margins than the CyberKnife. The CyberKnife is the most accurate radiation out there. We can treat with 3- or 5-millimeter margins.

I am convinced that we can also treat with 2-millimeter margins. We don't-- You don't have failures in prostate cancer on the margin when you're treating with a CyberKnife. We need to probably work on protocols in the future for dose escalation, but we are not having marginal misses. And this is important because local failures happen when you have marginal misses. Local failures happen 10 years down the road. So if you use an inadequate technology, you're not gonna find out about your failures until 10 years down the road. I've been treating with the CyberKnife for 17 years. I've treated 2,300 patients. We don't have local failures due to inadequate dose in intermediate patients, so I feel very comfortable with our technology. I wasn't the first to do it. They started it at Stanford.

Another great thing about our technology is that any center can do it. The CyberKnife machine is almost idiot-proof. Anybody, any radiation oncologist in the world can start their prostate CyberKnife program tomorrow, and they'll be able to do an outstanding job and be able to treat prostate cancer in five fractions. They'll be able to sleep at night because they know that they're giving a good treatment. I love my job. I go to work every day knowing that I'm giving the best treatment for my patients. And Accuray did not, like, only just, you know, give us the machine. They sponsored a large trial showing that the five-fraction approach is a great way to treat prostate cancer. And not only do they feel so confident in their technology, that they give a higher dose to the prostate than other centers do.

So they give 7.25 to the periphery of the prostate, but they're capable, because of their accuracy, of giving 8 Gy × 5 to the center of the prostate, and that's gonna give us better long-term control. What they've shown in the PACE study, which is an amazing study from Europe, is that comparing conventional fractionation to five fractions is that there is actually less toxicity when you use five fractions with the CyberKnife versus using other linear accelerators. The Royal Marsden is an outstanding institution. It's an academic institution. They did a great job with this trial, and they showed that the CyberKnife has less late toxicity. And what they've shown is that you can give five fractions. No one should be doing 40 fractions of radiation anymore.

No one should be doing 25 fractions of radiation anymore for low to intermediate-risk prostate cancer. It is criminal not to do five fractions, in my opinion. I'm actually lucky that I have Seth here with me today because he's the person who's shown how important correction for rotations are. This slide shows his work, when he was at Winthrop, with Jonathan Haas and Dr. Lischalk, showing that if you don't correct for rotations, you get increased toxicity. What does that mean to a 40-year-old guy? It means, or a 70-year-old guy. It means that they're running to the bathroom because they have bowel frequency urgency. I don't want 70-year-old guys running to the bathroom, tripping, falling, and breaking a hip because they have bowel urgency after treatment.

Because we have such great technology, we can treat retreatments, we can do very complex treatments, so the CyberKnife allows the treatment of recurrent prostate cancer when no one else wants to do it because they don't want to take the risk that their technology isn't accurate enough. And this allows Dr. Fuller, who's a great guy, who works in San Diego, who's treated many men with recurrent prostate cancer using the CyberKnife. He has shown that it's very safe. Amazing PSA outcomes. The PSA nadirs are spectacular, as good as brachytherapy. And he's shown that you can do this all with very minimal toxicity. And if you're going to do treatments in the future that have even less toxicity, you have to do focal treatments, and focal treatments require even more accuracy.

Because we have sub-millimeter accuracy, I know that I can do focal treatments with the CyberKnife. And even if, you know, if something moves as you're trying to do a focal treatment and the, and the prostate's moving and you're not tracking it, you're going to miss the target. I have confidence with my CyberKnife that we're doing continuous tracking and that we're going to hit the targets. And we don't need, with the CyberKnife, I don't think we need rectal spacers, and we don't need gels because we have such accuracy that we can treat with tight margins. I think every other user who's doing SBRT, who doesn't have a CyberKnife, they probably need a gel between the prostate and the rectum.

If you have a CyberKnife, you can have the confidence that you're treating with tight margins and you don't treat a lot of rectum, so you probably don't need the gel. I'm actually happy that I'm one of the first people in the world that actually got to see the Radixact demos today at the Accuray meeting. I think it was a brilliant partnership, Accuray combining with Limbus AI, because Limbus AI is a bunch of really smart young guys. They are guys, by the way, smart young guys. And they are using automated contouring, and they're gonna make it really quick for the Radixact to adjust to daily changes in motion, and they showed me this week at their booth.

Also, the Radixact is one of the, is a tracking device, so it allows us to track the prostate. Not as good as a CyberKnife, but pretty good. So I think that for people who don't have a CyberKnife, the Radixact is gonna be an excellent alternative for treating five fraction prostate. And I wanna thank you guys for letting me be here. I've already learned, I sat here for the last 30 minutes, and I've learned a ton about radiation oncology and the business of radiation oncology, and I wanna thank you guys for bringing me here.

Seth Blacksburg
Chief Medical Officer, Accuray

That was wonderful. Thank you, Sean. Our next speaker is Dr. Jon Lischalk. So Dr. Lischalk is the Medical Director of the NYC CyberKnife and Director of Research for the Department of Radiation Oncology at NYU Long Island School of Medicine, where he's an assistant professor. Dr. Lischalk received both his undergraduate and medical degree from the University of Washington School of Medicine and completed a residency at Georgetown University Hospital, where he served as a chief resident in his final year.

Dr. Lischalk has authored over 40 peer-reviewed medical publications, book chapters, and delivered numerous presentations on the use of stereotactic radiation therapy to address urologic, thoracic, and intracranial malignancies. Prior to his tenure at the NYU Long Island School of Medicine, Dr. Lischalk led the thoracic and proton services at MedStar Georgetown, and he was named a top doctor by Washingtonian Magazine. He is regarded as an authority on the use of radiation to treat oligometastatic disease and is a highly sought-out lecturer to deliver talks on this topic. So thank you for joining us.

Jon Lischalk
Medical Director of the NYC CyberKnife and Director of Research for the Department of Radiation Oncology, NYU Long Island School of Medicine

Thanks, Seth. Okay, so today we're gonna be talking about a pretty exciting space that's opened up in radiation oncology, and I think oncology generally. Seth did a beautiful job kind of showing the volume changes that we're expecting over time. I mean, we've seen this change in conventional fractionation for a lot of disease sites moving into SBRT for lung cancer, for breast cancer, for prostate cancer. And I think we're gonna continue to see that, and the two spaces I wanna focus on today are oligometastatic disease and lung cancer. So here are some disclosures. So I think Dr. Collins, you know, explained this perfectly. CyberKnife, we've been using for over several decades now. I've been using it for over a decade, and Radixact are really perfect platforms to be able to deliver SBRT.

As the volume for SBRT increases, I think this is gonna find its utilization increased. If you look at the next five to 10 years, SBRT overall, I think is gonna, is really gonna blow up. We've already seen it in the last five years, but focusing now on oligometastatic disease, what, what is this concept? Well, you know, for, for a very long time, we've looked stage 4 disease very differently than we do now, and, and we're starting to understand that metastatic cancers is, is a massive burden in the U.S. Over 600,000 patients are living stage 4 cancer in the U.S., and that's just for the first 6 most common cancers combined.

So if you add in the rest of the cancers, this is probably close to 1 million patients just in the U.S., that are dealing stage 4 disease. But based on a number of big trials that have come out in the last five years, we're starting to realize that metastatic cancer is no longer this hopeless state, and that utilizing radiation very aggressively can really change the outcomes dramatically for these patients. So using SBRT or, or SABR to deliver radiation very quickly to metastatic disease sites can extend the life expectancy for these patients, over 600,000 patients in the U.S. And the numbers are pretty dramatic here.

So if you look at metastatic cancer, the five-year overall survival based on this trial published out of Canada by Dr. Palma, the difference in survival was 42% versus just under 18%, and that's a huge impact. This has really been a panacea for our field. We're starting to look stage 4 disease very differently with the utilization of SBRT in these patients. And what's very interesting about this is that radiation therapy now has stronger data supporting its efficacy than even surgery or other ablative therapies. RFA, cryo, things like that. Really, the level one evidence supports using SABR and SBRT to help prolong the lives of these patients.

Now, when we look a little bit closer at volume, the numbers are a little harder to tease out, but there are some recent publications that show oligometastatic disease, which is a subset stage 4 lung cancers, could be present in up to 50% of patients that are diagnosed stage 4 disease. So that's a lot of patients.... It's also gonna be dependent on how we define oligometastatic disease. Right now, we define it as having five or fewer sites that are metastatic for a given patient. But based on a number of new trials that are gonna be coming out in the next probably five to 10 years, that definition might even expand further, maybe up to 10 metastatic sites, all of these sites receiving SABR.

And this is another trial being conducted by Dr. Palma in Canada, looking at using SABR, SBRT, to all of these sites of disease, and to improve overall survival. That's their primary outcome in this trial. So if you kind of just look at the numbers here, SBRT for oligometastatic disease really may skyrocket in the next five to 10 years. I wouldn't be surprised if there's entire specialties in radiation oncology entirely dedicated to specialized treatment for oligometastatic patients. stage 4 patients, plus up to 50% of them, maybe more, with oligometastatic disease at their diagnosis, treating up to five sites, maybe 10, depending on what the next SABR-COMET Trial shows. You're looking at a lot of treatments for these patients and really a game changer across the board. So oligometastatic disease is definitely something that we're very excited about in the field.

We're seeing more and more referrals for this, and I think it's gonna dramatically improve the survival and, and quality of life for our, our patients. What about lung cancer? So we've been using SBRT for lung cancer for over a decade now. I trained at Georgetown with Dr. Collins and Dr. Brian Collins, who really pioneered utilizing CyberKnife to treat early-stage lung cancer. So it's been around for a very, very long time, but a few things have really changed dramatically in the last five to 10 years, where I think we're gonna start treating quite a bit more lung cancer. Let's look at the burden of disease. So lung cancer is really just a dramatic burden on patients in the United States. It's really, it's the number one cause of cancer-related death by a long shot.

The other five most common cancers combined actually don't equate to the mortality that lung cancer has. So we really have to do a better job, and how are we gonna do a better job? I think the big thing is gonna be screening. Now, there's a lot of screening tests for a variety of different cancers. Colonoscopies detect colon cancer, breast cancer is detected with mammograms, and CTs are used now more and more to identify lung cancer in patients that are at high risk. Now, this trial came out over a decade ago. It was published in The New England Journal of Medicine, and it shows that lung cancer mortality, if you use low-dose CT scans to screen for lung cancers, is lower, and death from lung cancer actually goes down as well.

A few years ago, in Europe, a similar trial was replicated that showed the exact same thing, that you could reduce cancer-related death, and most importantly, that you can take a disease site where 60% of the patients at presentation are diagnosed with incurable cancer and pull them into a curable setting where you're treating earlier stage disease. And that's what SBRT is used for. So between these two screening trials, I think we're gonna start seeing a dramatic increase in lung cancer screening in the U.S. and abroad. So what do the numbers kinda look like here? Well, I think in the next decade, we're not only are we going to see an increase, we have to see an increase in lung cancer screening.

A recent study out of this institution here showed that only 18% of patients that were eligible for lung cancer screening underwent low-dose CT scans. So that's a lot more patients that need to be screened for early-stage lung cancer. And how many patients is that? Quite a few. The American Lung Cancer Association actually estimates over 14 million patients currently meet the United States Preventive Services Task Force recommendation for early lung cancer screening. So we're gonna see a big increase, and we're already seeing it at different institutions trying to implement more and more lung cancer screening for this patient population. So that is going to rise over the next five to 10 years. And that's where SBRT comes in.

I mean, if you're screening for these patients, a lot of the times you're screening an older patient population, sometimes frail, sometimes patients that have a lot of cardiopulmonary disease, a lot of patients that really aren't eligible for surgery. You know, opening up a chest, taking out part of a lobe of a lung, that's a lot for somebody of that age and with those types of comorbidities. We already know SBRT cures patients with early-stage lung cancer. We've been showing that over the last 15 years, and all the data shows the local control for a lung cancer such as this, treated with SBRT, with CyberKnife, is over 90%. So we know SBRT works, and it's the standard of care in the medically inoperable setting.

But in the next five to 10 years, we might even see it translate into the medically operable setting. So we kind of simultaneously have two things happening here. We're screening for more patients to identify more early-stage lung cancer, and we could have three randomized trials that show that SBRT is not inferior to surgery and will be pulling even more, more patients into the SBRT setting. So these three trials that I listed here in the parentheses will be published in the next 10 years, and we'll be able to answer that question. So I think we're, we are also going to see a huge rise in SBRT for early-stage lung cancer in the next five to 10 years.

So if you take these two states and kind of put them together with a revolution in oligometastatic disease treatment paradigm, kind of capturing an entire new subset of patients that we never, never treated before, as well as the expansion of lung cancer screening, I really would predict that SBRT is gonna really dramatically expand into new disease sites and for new patients in the next decade. Thank you.

Seth Blacksburg
Chief Medical Officer, Accuray

Thank you, Dr. Lischalk. Our next speaker is Dr. Aghdam. Dr. Nima Aghdam is an esteemed expert in the treatment of central nervous system malignancies at Beth Israel Deaconess Medical Center, where he lectures on anatomy and physiology. He's an instructor of radiation oncology at the Harvard Medical School. Dr. Aghdam received his undergraduate education at UC Berkeley and received his medical degree from Georgetown University Hospital, where he subsequently completed a residency in radiation medicine. Dr. Aghdam has published widely on the use of stereotactic body radiation therapy techniques involving CyberKnife robotic technologies. He maintains an extensive database on applying this technology towards the treatment of benign and malignant brain and skull-based lesions. We're absolutely delighted to welcome him today. Thank you.

Nima Aghdam
Instructor of Radiation Oncology, Harvard Medical School, Beth Israel Deaconess Medical Center

Thank you, sir. Thank you, Seth, and thank you all for inviting me for a talk today. I'm going to speak to you about two broad categories of central nervous system pathologies, primarily malignant, with a focus on brain metastases, followed by a few slides on topics of special interest to me, including benign and tumors and benign conditions. These are some of my disclosures. The incidence of brain metastases is rising, and part of that is from what Dr. Lischalk alluded to. It's that new systemic agents such as targeted therapies and immunotherapies are certainly increasing the survival of our patients with metastatic cancer. This is an incredible opportunity for all of us, and many of our patients are delighted to live longer.

But unfortunately, very few systemic therapy options are available for intracranial metastases. Because of the biology of the brain and because of the nature of these particular agents, the tumors in the brain still pose a great deal of concern for many of us. And as patients live longer, the utility of radiosurgery remains critical in management of this population, and CyberKnife has had a wonderful track record in taking care of patients in this space. I'd like to point out something about CyberKnife as I use it all the time. It is not merely a tool for radiation oncologists. It's a tool for a multidisciplinary effort to take care of our cancer patients, and that's a critical component of how we take care of patients with complex systems. We are not working in a silo.

We work with neurosurgeons, we work with neuroradiologists, neuro-oncologists, and developing a program around this wonderful device takes a small village. Not only the people in this room, but also the folks who are within each individual hospitals from different disciplines. And that not only adds value to the device, but it also makes the device a tool that is used by our team beyond merely radiation oncologists. CyberKnife advantages in this area are well storied. I mean, it minimizes the dose to the normal tissue by focusing the radiation to the small brain metastases. This has been shown to improve the quality of life and cognitive function of patients. There is excellent technical superiority in treating many brain metastases at the same time and over a period of time, and it is far more convenient for my patients.

As someone who had experience with alternative platforms, we find patients to be much more comfortable getting through this treatment with a mesh instead of a frame that gets screwed in their head. Making metastatic cancer a chronic illness is a motto that you've already heard from Dr. Lischalk. As patients with brain metastases had a median survival of somewhere around nine to 14 months in the past, suddenly we see plethora of data suggesting that patients can live for years now with metastatic disease of the brain. With routine imaging, timely detection, and treatment of additional metastases, not only we add value to the patient's quality of life, but we truly make metastatic disease a chronic illness. CyberKnife has a wonderful track record. I use this device every day. My colleagues use this device every day. We've all treated brain mets.

It is feasible to deploy this device in the community and have a fantastic radiosurgery product that's ready to go out of the box, and that's something that Sean alluded to with the prostate program. We move to benign tumors, and although individually, there aren't many brain tumors, as a constellation, there is actually quite a few benign tumors of the brain that are treated with radiosurgery products, including CyberKnife and meningiomas is a large percentage of this, about 30% of brain tumors that grow from the inner outer lining of the brain. Although these are called benign, I would imagine nobody wants a growth in their brain, and real estate is quite expensive in the brain. So you find yourself pressing against very important individual components of the brain.

And for that reason, my esteemed colleague, Dr. Sean Collins, led this effort to treat patients with CyberKnife, one of the early adopters of this treatment. Over five treatments, you were able to get 100% local control of this disease. This type of treatment has been performed over and over again. There are centers of excellence that do this, and what makes this treatment special is that no one gets cut. The brain does not need air. Patients may have side effects, but these side effects are typically minimal. And as we advance our imaging modalities, not only MRIs, but also new agents such as gallium dotatate, we are able to refine this treatment modality.

When we refine things, we need a device to match the refinement in imaging, and CyberKnife truly offers an ideal platform to treat these complex meningiomas, especially near very important real estate in the base of the skull... Another area of interest of mine and my colleagues is vestibular schwannoma. These are tumors that are in the cranial nerves that function as the conduit for sound into your brain. So this is what makes you hear. These tumors in the lining of the nerve sheath can be very small. They can be asymptomatic, or they can make you deaf, or at times they can compress the brain stem.

What we have seen is that with the platform, such as CyberKnife, but in particular CyberKnife, we can preserve the hearing of the patients while treating these patients with extremely high patient-reported satisfaction. Again, this statement I steal from Sean, it's not enough to treat our patients. We know how to treat cancer. We know how to treat brain tumors. We know how effective our modalities are. It's important for our patients to be satisfied with those treatments. You can cut someone open and scoop out that tumor, but there's significant morbidity associated with that, which we simply do not see with CyberKnife. pituitary adenomas present another difficult treatment for our patients. I don't assume all of you guys are neuroradiologists, but unfortunately, pituitary is in a very inconvenient spot, compressing the optic apparatus.

We are talking about millimeters away from the most important nerves, which I assume are in the base of the skull. Your vision will be lost if the pituitary adenoma presses against it, and your vision could be equally lost if your treatment modality causes damage to that optic nerve. We've been fortunate enough to utilize CyberKnife for pituitary adenomas now for about 13 years in my current institution, and I know that Sean has been using it for many years. What we've seen is minimal toxicity with excellent local control both for functional pituitary tumors as well as non-functional ones. This comes at a real cost. Oftentimes, there are surgical complications with treatment of this particular disease at this particular location.

You could have damage to the nerve for the vision, you can have damage to the vessels, you can have leakage of the fluid in your brain, you can cause permanent thirst and hunger, you can cause diabetes insipidus. These may seem like some abstract condition in a medical textbook, but we've all seen these as a consequence of surgery. Why I bring this up is that radiosurgery is truly a competitor to surgery in this space, and I think that it's important to make that point. That we are not just taking over other types of radiation, but we are taking over, as Sean's work and as Dr. Lischalk's work has shown, we're taking over the surgical space, which is becoming increasingly of interest to our patients.

If we can offer them something that is not surgical, I think that our patients would be grateful for it. Trigeminal neuralgia and AVMs are the final two conditions that I treat, and I really enjoy treating these because when you meet someone who feels that a sharp knife is piercing through their face, you start realizing that you are in this field to care for people, to help them. These patients are suicidal. These patients are at the end of their wit. And I have managed several of these patients, many patients with trigeminal neuralgia, and I know that Sean has treated many patients, and the treatment is extremely effective. And I want to show you why this device is so particularly good for doing this type of treatment.

As you can see, that's just mere millimeters away from some very important organs. The target itself is no more than four or five millimeters, and radiosurgery with CyberKnife has shown itself to be extremely effective in controlling the pain in this patient population. I also treat arteriovenous malformations, which are an unfortunate misalignment of veins and arteries in the brain. CyberKnife has slowly taken market share away from other radiosurgery modalities, and the reason for that is because you get a very good platform to deliver this treatment without investing an enormous amount of time from the neurosurgeon and the radiation oncologist. And the other Dr. Collins has a report on the intermediate outcomes for CyberKnife for these patients, and he has had extremely good closure rate for these very complex and very dangerous conditions.

The future direction is very clear to me. We are seeing an increase in volume of metastatic tumors, including metastatic brain tumors. There is increasing data supporting the use of CyberKnife in management of benign tumors of the brain, and there's excellent data on the use of CyberKnife treating AVMs and trigeminal neuralgia, suggesting that the hardest CNS tumors and conditions can be routinely managed with CyberKnife. Thank you all for your attention.

Seth Blacksburg
Chief Medical Officer, Accuray

So I, I am delighted to turn the podium over to Awais Mirza. Awais is a highly skilled and prominent radiation therapist and hospital administrator who joined Accuray, and Awais heads our patient access and health economics arm for the Americas of Accuray. So Awais is gonna chat a little bit now.

Awais Mirza
Director of Patient Access, Accuray

Thank you, Seth. As you have heard from our key opinion leaders, they have clearly articulated the direction in which the field of radiation oncology is moving towards. We are seeing an increase in the utilization of hypofractionation, which are shorter treatment sessions, and stereotactic radiation therapy, which are five or less treatment sessions.... Accuray believes that as the field continues to evolve, so should the payment rates, and our providers should be financially compensated accordingly. You have heard us talk about value-based healthcare for the past number of years. CMS released a radiation oncology alternative payment model in 2019, and immediately, Accuray became supportive of that initiative. However, this model was not adopted due to concerns related to payment discounts and the administrative burden that would be placed on providers.

Accuray supports the basic principles of value-based healthcare, which are listed on the screen here. Our solutions, CyberKnife and Radixact, allow patients to have access to quality care in a shorter treatment course, which increases a patient's compliance and reduces patient, financial burden. Accuray systems provide safe treatments with improvements in imaging and the use of Synchrony. Accuray solutions, paired with value-based healthcare, allow providers to choose the appropriate treatment option for their patients rather than making clinical decisions directed by model policies established by insurance companies. The goal for value-based healthcare is to allow the physician and the patient to decide the, decide on the best course of treatment for that specific patient. Accuray continues to advocate for value-based healthcare in radiation oncology and is supportive of the latest Radiation Oncology Case Rate, also known as ROCR, which was proposed by ASTRO earlier this year.

We are extremely fortunate to have Dr. Connie Mantz here to discuss more on value-based healthcare and ASTRO's ROCR policy. Dr. Connie Mantz is a radiation oncologist and chief physician executive for a large radiation oncology group practice. He completed medical school and residency at the University of Chicago. In his career, Dr. Mantz has engaged in many health and government policy initiatives pertinent to radiation oncology, including the development of Medicare and commercial insurance coverage policies, development of new procedure codes, and determination of payment rates. He has been a consultant to Medicare and all major commercial insurance companies on value-based payments and helped create the first comprehensive bundled payment program in radiation oncology back in 2011 with Humana. This program has served as a basis for Medicare's radiation oncology payment model, as well as radiation oncology's latest Radiation Oncology Case Rate model. I welcome Dr. Connie Mantz.

Connie Mantz
Chief Physician Executive, 21st Century Oncology

Thank you, Awais. Thank you, Seth, for inviting me to speak. As Awais referenced, our topic for this part of the talk is recent trends that we've seen in the utilization of radiation therapy and in particular, how they come to a head as it has to do with the thinking around the development of alternative payment models. Disclosures and disclaimers, I have none. Our key takeaways: We'll focus on three topics. We'll review recent case mix and utilization trends in radiation oncology and project what the field may look like through the end of the decade. We'll discuss how these trends are contributing to the thinking that radiation oncology may be better served by an alternative payment model rather than fee-for-service.

We'll discuss a legislative proposal of a payment program named ROCR and compare it to Medicare's RO Model, a different alternative payment program that has been recently put on indefinite hold. To look at recent trends, we used Medicare claims data for radiation oncology services between 2015 and 2021. Claims were organized into episodes of care covering all RO services furnished to patients during a 90-day period. Each episode was assigned a diagnosis and method of treatment. Medicare patient numbers, according to treatment year and diagnosis, and their growth rates are shown in the table. A few key observations we can make. RO largely provides its services to the Medicare age demographic. RO cases have increased by 2.2% per year on top of flat growth of Medicare beneficiaries.

When we roll Medicare Advantage into traditional Medicare, total Medicare enrollment has increased by 2.4% per year. We don't have access to Medicare Advantage data, but we can reasonably extrapolate that overall RO patient growth is greater than presented here. The other key observation is that our high-volume cancer types, breast, lung, prostate, and metastasis, which account for 70% of the total case mix, are, as a group, growing at a faster rate than the overall CAGR. When we project these trends to 2030 and forecast volume growth and case mix, we see a nearly 30% growth in patient volumes, largely driven by prostate and metastatic cases.

Note that advanced technologies such as stereotactic therapy and IMRT are standards of care for many of these cancer types, and so from the perspective of the purchaser, future CapEx needs need to be allocated for systems that can deliver these advanced treatments well. The improvements in treatment accuracy and precision enabled by these advanced technologies have promoted the use of fewer treatments per course.... However, fewer treatments apply a downward pressure on revenues under fee-for-service, particularly for non-stereotactic treatments, where per-unit pricing is less. At present, the growing demand for RO services buffers very effectively against declines in individual case revenue. To address the risk to individual case revenues, ASTRO and other stakeholders have looked to alternatives to fee-for-service to provide payment stability on a per-case basis.

Ideally, patient payments under a new model would be insensitive to the number of treatments prescribed and would better align financial incentives with best clinical practices, where fewer treatments are supported by evidence. A new system should, better than fee-for-service, adjust its payments to the inflationary effects on the costs of healthcare goods and services. ROCR, or the Radiation Oncology Case Rate Model, is a proposal developed by ASTRO physicians and consultants as an alternative to fee-for-service. ROCR would issue a fixed base rate for each of the 15 most common cancer types treated with radiation therapy. The base rate would be calculated as a weighted average of total payments for each cancer type during a course of care. Included cases would be those treated by external beam therapy and stereotactic therapy. ROCR would also update base rates annually through inflationary adjustments.

ROCR is a legislative proposal and not a proposal made directly to Medicare. As such, a minor savings adjustment would be needed and applied to the program's payments in order to receive a favorable cost score to support its passage. Here we show a revenue projection that compares ROCR payments to current Medicare fee-for-service. The bar graph shows average case payments under fee-for-service in blue and ROCR in orange. After an initial period where payments are discounted to provide a required level of savings for congressional approval, ROCR payments stabilize and then begin to rise slowly, while fee-for-service payments continue their downward trend as fractionation is anticipated to continue to decline. This table shows total technical payments for all cases. ROCR outperforms fee-for-service by about $390 million over the five-year period between 2024 and 2028.

ROCR differs from Medicare's RO Model, most critically in terms of payment method and participation, where the RO Model would apply a negative adjustment annually to its base rates to reflect declining fee-for-service payments observed in the rest of Medicare. ROCR would completely uncouple from the fee-for-service system. Also, ROCR would eliminate the various discounts and withholds of the RO Model to improve cash flow for the provider. To distribute the savings requirement more equitably, ROCR would involve 100% of the provider base, whereas the RO Model would have randomly selected 30%-40% of providers and imposed the full savings requirement onto them. Finally, ROCR would replace the administrative burden of quality data maintenance and reporting, as would have been required under the RO Model with practice accreditation, a simpler-to-administer process and one that would better reflect actual clinical quality. Thank you, everyone, and that's it for my part.

Seth Blacksburg
Chief Medical Officer, Accuray

We'd like to thank our key opinion leaders for sharing their insights on the evolving trends in radiation medicine. As you've heard, we're highly confident that our technology puts us in a prime position to capitalize on these opportunities. It's my pleasure to welcome to the podium Ali Pervaiz, who's our Chief Financial Officer.

Ali Pervaiz
CFO, Accuray

Good afternoon, everyone, and thank you for joining our investor event. I'd like to start off by recapping our fiscal 2023, which ended June 30 of this year. We had a very strong performance, both from an operational and financial standpoint, despite all the macroeconomic headwinds related to supply chain constraints, inflation, and foreign exchange headwinds. In FY 2023, we hit a historic revenue milestone with $448 million of revenue, which represents a 24% growth in system unit volume versus the prior year. Had it not been for the impact of foreign exchange, our revenue in FY 2023 would have been approximately $18 million higher at $465 million, almost all of which would have contributed to adjusted EBITDA.

We had an impressive 5% growth in our global installed base, which is in line with our service revenue growth once adjusted for the impact of foreign exchange headwinds, which is a good indicator that our efforts focused on our service business are starting to take shape, as we believe this business will be a positive revenue and margin contributor going forward. In FY 2023, we had a strong focus on working capital optimization and came out of the year with a healthy cash balance of $90 million and positive free cash flow. This, along with strong OpEx management focused on a return on investment, will really contribute to our margin expansion efforts over the next three years, which I'll speak to in greater detail. Lastly, we delivered adjusted EBITDA of $24 million, representing a 5% growth.

It's very important to note that if we adjust this number for the impact of foreign exchange, which was roughly $18 million on the top line, and inflation, which was a $5 million headwind, we would have delivered an additional $15 million-$20 million of adjusted EBITDA, putting us north of $40 million. So despite the macro headwinds, we're proud of what our team's accomplished in fiscal year 2023.... Moving to fiscal year 2024 and beyond, our financial strategy is focused on three main pillars. Number one, predictable revenue growth by focusing on bringing in high-quality orders that convert to revenue within 30 months, resulting in a high single-digit unit volume growth, which will further contribute to our service revenue growth.

Secondly, margin expansion to unleash an EBITDA CAGR of 20%-25% over the next three years, resulting in a doubling of adjusted EBITDA as a percentage of revenue over that time horizon. Lastly, strengthening the balance sheet by improving our cash position through working capital optimization and exploring avenues to improve our capital structure and reduce overall debt. As stated earlier, one of our biggest priorities going into fiscal year 2024 and beyond is delivering predictable revenue growth. This will come in the form of unit volume growth, anticipated to have a 6%-8% CAGR in the coming years, which will be fueled by our new innovations and our penetration into the value segment.

This increase in installed base will help grow our service business over the coming years, and we anticipate our recurring revenue from service to go up from 42% today to the high 40s as a percentage of total revenue. Additionally, our enhanced customer-centric service solutions will really help drive our service revenue. Overall, we anticipate a 4%-6% revenue CAGR over the next several years, with balanced contribution from all of our regions as we penetrate into the value segment. Delivering margin expansion is another key priority over the next several years, and a lot of this effort has already been activated in fiscal year 2023, and we will continue to work on it in fiscal year 2024. Our margin expansion strategy is focused on four main pillars. First, pricing accretion.

We have armed our commercial teams with enhanced tools and have aligned their incentives to optimize price and are starting to see early signs of more profitable orders contributing to our backlog. On the service side, we're looking at all of our contracts and are adjusting pricing due to inflation and also to drive the right profitability. This, coupled with customer-centric offerings, will help drive service top line and margin growth. Additionally, we're focused on reducing our cost to serve by driving efforts to reduce parts consumption with better quality and through driving efficiency with our field service engineers. In terms of operational excellence, we have a big focus on COGS reduction by working with our suppliers and engineering teams to drive cost out. Lastly, we have a strong focus on driving cost discipline to ensure that every dollar we spend has the right ROI.

This has been a cultural change that we feel is starting to yield the right results. All of our margin expansion strategies will help us deliver high single-digit to 10% adjusted EBITDA as a percentage of revenue over the course of the next three years, which is a 20%-25% CAGR and a doubling of adjusted EBITDA as a percentage of revenue. We anticipate having continued headwinds from foreign exchange and product mix as we penetrate into the value segment and expand to new markets, but see that being offset by volume growth in our margin expansion plans noted earlier.

An important area to note is that we will likely see our product margins challenged in the near term related to our China joint venture accounting rules, which requires to defer 50% of our margins till our product makes it to the end user, but we'll see them come back to a steady state once volume picks up. Finally, we're focused on strengthening our balance sheet by optimizing our working capital, by increasing inventory turns and reducing our DSOs. We recognize that cash is king and are maniacally focused on growing our cash reserves while paying down debt and generating free cash flow.

Pulling all this together and coupling our financial strategy with a high-performing culture, a strong operating framework, and strategic capital allocation, I believe that we can create some significant value for our customers, our shareholders, and our employees. With that, I'd like to thank everyone for attending. I think we're going to open it up for Q&A.

Elizabeth Kennard
VP of Global Marketing, Accuray

Yes. Yes, thank you. We are now ready to begin our Q&A session. I would like to invite the management team and our guest speakers to the stage. I do have a number of questions that have come in from our remote attendees. But as a reminder, if you are a remote attendee and you would like to ask a question, you can ask by typing it into the Ask a Question box.

If you are here with us live and you would like to ask a question, please allow us to bring you the microphone to ensure our remote attendees are able to hear your question. We will begin with a few of our remote questions here. Our first question, and this one I'm going to direct to Dr. Sean Collins. What do you believe needs to be done to increase the use of SBRT for indications where there is already good clinical data?

Sean Collins
Director of CyberKnife Prostate Program, MedStar Georgetown University Hospital

That's an excellent question. I was actually hoping that the payment for the whole course of treatment would have gone through. Because I guarantee you, if that model would have been moved forward, a year or two ago-

Elizabeth Kennard
VP of Global Marketing, Accuray

Mm-hmm.

Sean Collins
Director of CyberKnife Prostate Program, MedStar Georgetown University Hospital

Everybody would be getting five fractions of radiation therapy already. Me personally, I probably would have gone to two fractions of radiation - because I think that is the future of prostate SBRT, is two fractions. But I guarantee you that most centers would see the benefit of the five fractions a lot more quickly if that model would have come true.

Elizabeth Kennard
VP of Global Marketing, Accuray

Thank you for that. And this actually leads into one of our next questions, which, I'd like to direct towards Dr. Connie Mantz. So how do we think that the radiation oncology community will respond to the RO Model? Will it be a barrier or a catalyst to upgrading or purchasing new equipment?

Connie Mantz
Chief Physician Executive, 21st Century Oncology

And so, you know, first I should state that for all the groups with whom we've discussed this model during this meeting, and also other groups prior to this meeting, particularly the American Hospital Association and a few and some other organizations representing facilities, that the reaction to the model has been extremely favorable. That the stability of payment that it appears to ensure, particularly for a high CapEx, high OpEx business such as radiation therapy, provides confidence in order to make the CapEx commitments that the field and its physicians are going to be demanding as clinical data continue to accrue in favor of hypofractionated schedules and stereotactic treatment.

So, just to, you know, echo and amplify on Sean's point, it's a payment model like this that holds the provider and the facility owner of the equipment harmless from a financial perspective, to allow the physician to use his/her best clinical judgment and prescribe as clinically indicated, and as data support, shorter courses of treatment, including stereotactic therapy and many more applications than we see at present.

Elizabeth Kennard
VP of Global Marketing, Accuray

Thank you. One more for the management before we move on to some of our live questions that we have in the room. This one I'll direct towards Suzanne Winter. Can you provide more detail on the impact of the Tomo C introduction in China?

Suzanne Winter
CEO, Accuray

Yeah, no, absolutely. And I will start, and I'll hand it to Sandeep as well. The Tomo C product, first of all, it's our first jointly developed product with our China JV partner, CNNC. We're very excited about this milestone of getting the clearance, you know, primarily because it will allow us now to participate in the fastest-growing and the largest part of a market that is growing, you know, in double digits. It's an area, you know, of the world where radiation therapy is not nearly at capacity. The number of linear accelerators per cancer patient is well below the World Health Organization recommendations. And if you were to go to China, you would see at 3 A.M., you know, numbers of patients waiting in the waiting room to get radiation therapy.

And so, by participating in the Type B segment, you know, it, it's fulfilling one of our major pillars, which is patient access. And this is a product that is designed for throughput, efficiency, workflow to handle the masses of patients, that need to receive radiation therapy, but at the same time, getting advanced radiation therapy. But I'll let, I'll let Sandeep talk a little bit, too, just a little bit from a commercialization standpoint.

Sandeep Chalke
Chief Commercial Officer, Accuray

Sure. So we've already, like I said earlier, we already started our commercial activation plan. And with the approval, regulatory approval, it kind of gives us an ability to start quoting. And by the time we actually start shipping, it'll be another few months. But we're hoping that the reception that we have gotten so far through commercial activation is kind of gets converted to, you know, we picking up orders. We are geared up, like I said, we have a customer-facing team in China that are reaching out to different provinces, and this is Type B, essentially, is a provincial market that we are entering as we speak. And it's a phenomenal level.

All, you know, the quota that the Chinese government puts out is every five years, and that quota is quite significant for us to enter this market with this product. We believe this is going to be a quick installation, but also a heavily service-oriented market. So, we'll be preparing ourselves to not just enter the provincial market, but also be able to service the market at the right levels.

Elizabeth Kennard
VP of Global Marketing, Accuray

Thank you, Sandeep, and I know we do have a few questions in the room. Maybe we can start with Marie.

Marie Thibault
Managing Director, Medical Technology and Digital Health Analyst, BTIG

Hi, thank you so much for taking the questions. Marie Thibault from BTIG, and thanks for hosting this event. Very interesting. Wanted to ask a question that's probably for Ali. You know, maybe a two-part question, a little bit on the efforts on margins. You mentioned that products mix will be a headwind, primarily from the value market. Can you remind us of pricing, how you're thinking about Tomo C as well as Helix, and just how much of a differential there is on margins? And then, I guess a follow-up, you mentioned product mix is going to be challenged, near term, product margin will be challenged near term because of those accounting rules around China. What's near term? Is that 12 months, 18 months? How to think about some of that.

Ali Pervaiz
CFO, Accuray

Yeah. Thanks, Marie, for the question. You know, I would say, you know, we are going to see a headwind from product mix as we penetrate into the value segment, as you've noted, right? And we do have different configurations that we're going to be offering, specifically in the China market for Tomo C. So the pricing is actually going to vary up and down the spectrum a little bit. And I think same is true for Helix, right? So depending upon kind of where we penetrate Helix first, those different regions have different pricing dynamics, and so we're going to make sure that we're pricing them in an optimal fashion.

But I think what's really important to note is that, at the end of the day, this is really going to help us out from our adjusted EBITDA, and is really going to help expand our adjusted EBITDA as a percentage of revenue, and that's really what we're targeting through getting some of this volume leverage come through. And so that's really what we're excited about. You know, when it comes to the second part of your question in terms of the deferral, so the way it works is that because we have this joint venture relationship, once we actually provide the product over to Tomo, to our joint venture partner, and they manufacture it, then when it goes to the end customer, that's when we're able to obtain 50% of the remainder margin.

As they're coming online and building up their pipeline, that's just gonna take a little bit of time, and so we think it's probably going to be challenged, you know, probably for the next 12 months or so. And then once we start to get volumes back up in steady state, it should be a non-issue.

Elizabeth Kennard
VP of Global Marketing, Accuray

Maybe another question in the room, Neil?

Neil Chatterji
Senior Analyst in Medical Technology and Digital Health Equity Research, B. Riley

Hi, Neil Chatterji, B. Riley. Maybe just sticking with just the value segment. So maybe if you could just talk more about that expansion with Helix, you know, what differentiates Helix, you know, how that might be different than the Tomo C product.

Suzanne Winter
CEO, Accuray

Anything you want to add, Sandeep?

Sandeep Chalke
Chief Commercial Officer, Accuray

Sure. From a Tomo C product, you said?

Neil Chatterji
Senior Analyst in Medical Technology and Digital Health Equity Research, B. Riley

For Helix, for the emerging markets like India.

Sandeep Chalke
Chief Commercial Officer, Accuray

Yeah, so it's starting with India for sure. Helix is a version of Radixact that we are bringing. The current product is. But it is going to be a limited configuration product. So basically, we are defining the scope and the price range with Helix. We are going into a market where it's price-sensitive markets that we are entering with, and it's gonna be an India start because it's also regulatory-wise, it's a limited or least regulatory hurdle that we have in place today. But if you look at a market like India, which is growing fast and there is a difference, there is a gap from demand to supply perspective, and also the healthcare demand is pretty heavy.

WHO has defined different levels of radiation therapy equipment that is required in the country, but it's not supplied at that level. That essentially means we have to go to, go into tier two, tier three cities in India-like market will be defined by how we take the product. Today, we are discounting heavily on Radixact product as we go into Indian market. And instead of discounting the premium product, we are offering something which is fixed configuration or limited configuration to a market like India to take this forward. Does that help?

Neil Chatterji
Senior Analyst in Medical Technology and Digital Health Equity Research, B. Riley

Yes, that's, that's great. Just one follow-up. Just on Cenos, you know, if you could maybe just talk more about, you know, how that provides clinicians kind of a full, full toolkit for adaptive therapy, you know, how that might help with enhancing the workflow, the control, and then just your expected timelines for 510(k), and then also CE Mark.

Sandeep Chalke
Chief Commercial Officer, Accuray

Sure. I'll touch on the timelines, and I'll defer.

Suzanne Winter
CEO, Accuray

Yes

Sandeep Chalke
Chief Commercial Officer, Accuray

... the question to Seth, on the actual utilization as such. From— We have a 510(k) pending as we speak, at the booth in ASTRO here. By the time we expect the 510(k) and CE to be cleared by within calendar year 2024. We can't define the timeline because it is, again, dependent on both FDA and CE's clarity and questions and any explanation that we may have to give back. But we expect this will be a commercial product within fiscal next fiscal year. Yeah.

Suzanne Winter
CEO, Accuray

Let me just add also, too. With the online adaptive, certainly others have come to the market with online adaptive. I think that's been an advantage for us to understand those early revisions of an online adaptive capability. You know, what were the downsides? And one of the downsides was speed and the number of resources required to, you know, reevaluate and approve any change in a plan. And so much of what we did was try to take the capabilities and then enhance on the speed and, you know, how many resources would be required. And through remote collaboration, we are able to now have folks that are not in the department that can remotely take a look at the plan and improve it.

All of that still, we have to work within what the requirements are for the patient, but we now have the most comprehensive adaptive toolset in that we have an offline version, we have the real-time with Synchrony, which adjusts to changes intrafraction, and then between treatments now with the online adaptive. But I'll let Seth talk a little bit more about, you know, what you see as the potential.

Seth Blacksburg
Chief Medical Officer, Accuray

Sure. I'm happy to do so. So when you think about traditional radiation, the way that it's most commonly employed and prescribed, it involves a radiation oncologist mapping out the entire course of treatment at the time of sort of one event, which is called a simulation. And then traditionally, and most commonly today, the way that that ends up getting delivered is over a course of several weeks or so. And radiation oncologists have always known that the anatomy is gonna change because just as Dr. Collins was mentioning, in a way, you know, prostates are moving as we're here, and as we know, tumors shrink over time. We never had the technological ability to adjust for those changes in time.

Part of the reason that radiation has been fractionated, and you had these very long, protracted courses of treatment, is to take into account the fact that there was an uncertainty. There was an element of uncertainty in terms of the target, uncertainty in terms of the normal surrounding tissues. What we're seeing is that our technology, as I mentioned earlier, we have this confluence of technologies that are really allowing our products to be maximally utilized. When we think about personalized medicine in general, and then specifically in the oncology space, that involves taking into account the trends and changes.

As Suzanne was mentioning, adaptive therapy is just a way of saying, you know, more personalized therapy, that you're gonna take into account these changes, and you could do so in a quick and rapid manner and a very precise way. Traditionally, when we think of adaptive therapies, there are three different types. One type, Accuray has always done well, and so we are the motion management company. You've heard evangelical physicians, myself being one of them, who have espoused the virtues of being able to take into account a tumor as it's moving. We've called that Synchrony, and the language didn't exist at the time, 20 years ago, but that's currently characterized as in-line or real-time adaptive technology.

And so we were probably 20 years ahead of the times on that, and we're currently ahead of the times on that because our competitors don't have that capability. The two areas that have grown a little bit in intrigue and interest, and you've heard at the proceedings of ASTRO, is offline adaptive and online adaptive. And again, it's a continuum of being able to adjust for change. Offline adaptive refers to taking into account in between treatments, so the patient's not even in the department. You could look at the day or several days prior and see what the dose added up, what it looked like now with the imaging that you have available, and again, traditionally, we didn't even have this capability. And so Accuray has had a product on the market for that and is extremely exciting, and clinicians enjoy using that.

Online adaptive refers to taking into account at the point of intrafraction while the patient's on the table. So our announcement at ASTRO, I think it's generated tremendous buzz and interest. Most physicians don't, in our minds, segregate adaptive in these ways. We think of it in sort of the overall gestalt of how am I going to deliver treatment and give it the ultimate personalization, and we really have the full complement at this time to do so.

Suzanne Winter
CEO, Accuray

Neil, I think you asked about timing. So let me answer that. You know, we have 510(k) pending, and again, you know, we're at the mercy of the regulatory process. But I think our best estimation that we'll be able to take orders and ship within the calendar year 2024.

Elizabeth Kennard
VP of Global Marketing, Accuray

Thank you, Suzanne, and thank you, Dr. Blacksburg. And as a quick follow-on to that, I'd like to open this up to any of our esteemed guests who may have had the opportunity to see Cenos or would like to share their opinions. But can you share your views on Cenos online adaptive capabilities and how you envision incorporating tools like that into your practice?

Sean Collins
Director of CyberKnife Prostate Program, MedStar Georgetown University Hospital

So I actually think that we, as CyberKnife prostate users, I already am used to going to the machine, looking at the goal markers, seeing if they're accurately set up, making a decision with my therapist about whether it's safe to proceed. So when I use the Radixact and I do five fractions, I envision the same thing. I'm gonna go to the machine. I'm blessed that I have amazing therapists. They're gonna show me the adaption, they're gonna show me the new plan, and I think it's gonna be a very quick process that once we get used to doing it, I'm just gonna sign off on the plan and move forward. But I'd be curious to hear how my other colleagues feel about it.

Nima Aghdam
Instructor of Radiation Oncology, Harvard Medical School, Beth Israel Deaconess Medical Center

So I treat some head and neck cancers, and I think that that's the area where we'll see a great deal of adaptive therapy really manifest its value in patients' quality of life. As the tumor shrinks, you have the capability of shrinking your treatment volume, and if you're careful and safe enough, you can see the quality of life truly manifest years down the line in the preservation of function and salivary function, gustatory function, and swallowing function. So I think that there's going to be great benefits on personalizing treatment in the interfractional level. We will see a new revolution, we didn't talk about this today, in the GI oncology space, and we're going to see areas of the body which are highly susceptible, not merely to predictable motions, but unpredictable motions, unpredictable filling of bowels, unpredictable respiratory motion.

I think that we're going to see this type of technology coming from a platform that is well known for motion management to be the perfect complement, as Seth mentioned, to personalizing care, especially in the upper abdomen, as we see these enormous doses going into that area. This would directly compete with other modes of radiotherapy and we'll have the deep bench of both science and clinicians who are used to using Accuray technology.

Seth Blacksburg
Chief Medical Officer, Accuray

You know, I think from a oligomet standpoint, when you're seeing tumors that show up basically anywhere, you know, we're always treating a prostate or we're always treating certain places in the lungs, but when a met can come, kind of pop up anywhere, and you're dealing with different organs that are surrounding that tumor, you really have to be confident that you're hitting the right spot. And I think it really lands on motion management, which I think we've talked about a lot, accuracy, and then, you know, adaption.

And so I think as we start expanding the utilization of really high-dose radiation into a variety of sites that may not be totally familiar, that's gonna be all the more important, and you can have a lot more confidence, as, uh, Dr. C orkum said that you're not gonna cause late, late side effects. And so that's, that's one thing we don't wanna do in metastatic disease, is cause additional toxicity, because these are patients that are already going through a lot. And so we're trying to thread that needle and make sure that that therapeutic window is nice and wide so that these people can live longer but have minimization of, of toxicity.

Elizabeth Kennard
VP of Global Marketing, Accuray

Thank you. Our next question will be directed to our management team. Can you tell us a little bit more about why we decided to move our headquarters to Madison?

Suzanne Winter
CEO, Accuray

Sure. You know, I'll start, and I'll let Ali speak a little bit more. I, you know, we obviously we had two locations, you know, main locations here in the U.S., you know, in Sunnyvale, which has been our headquarters, and all of our manufacturing and our R&D are now located in Madison, Wisconsin. It made, I think, tremendous sense to move our headquarters, to Madison just because of the majority of our office-based employees were there. It is the center of our manufacturing. It is now this global center for our education. As we said, we think we'll get additional benefits and,

... and visibility at a governmental level. You know, in Wisconsin, we had our ribbon cutting not too long ago, and we had the mayor, we had representatives from Senator Ron Johnson's office. So I think that, you know, our participation in the workforce, in the Madison area and in Wisconsin overall, is very valued. It's also a tremendous workforce there. You know, we have a healthcare that is centered in Madison. Epic has their headquarters there, Exact Sciences is there, and of course, all of the University of Wisconsin that is located there with just tremendous skilled workforce. The quality of life is outstanding. So for all those reasons, it's just been, I think, a wonderful decision for us. At the same time, I think, it also allows us to have a lower cost for facilities. I'll let Ali talk a little more about that.

Ali Pervaiz
CFO, Accuray

Yeah, I know exactly. I mean, I think, you know, obviously there's definitely strategic reasons to be able to move to Madison, but you know what I mean, we are looking at everything from a financial lens. We are really challenging ourselves to be more cost disciplined. We are making sure that margin expansion's at the forefront, and these are difficult decisions to make, and you know, we are certainly walking the talk. I think strategically it made sense. From a cost perspective, it definitely made sense. And so we're really proud to call Madison, Wisconsin, our headquarters.

Elizabeth Kennard
VP of Global Marketing, Accuray

Excellent. Thank you. We have time for maybe one more question here in the room.

Marie Thibault
Managing Director, Medical Technology and Digital Health Analyst, BTIG

Thank you for letting me wrap it up. Marie Thibault from BTIG. Wanted to direct my question to the physicians. Thanks for your lending your expertise and teaching us about what you do every day. You know, every year we come to ASTRO, and there's something new from Accuray, and it - a lot of it's been on Radixact of late, you know, Volo Ultra and Synchrony and ClearRT, et cetera, and now, y- adding Cenos to it. You're all Accuray believers, but when you talk to your peers, do you think there's been a change in perception of the company over the past, say, five years? And if not, or if you need to convince your peers, what is it that they get stuck on? I'm just curious to hear state of the market.

Sean Collins
Director of CyberKnife Prostate Program, MedStar Georgetown University Hospital

You want... You go first.

Seth Blacksburg
Chief Medical Officer, Accuray

I'm happy to start on that. And I think a lot of it is it takes time for clinical data to mature, and it takes time for people to feel comfortable. And I mentioned earlier, I think in many ways, Accuray was ahead of its time. We had developed this incredible technology, but sometimes clinical data is glacially slow, as folks know. And we had an event on Sunday, a prostate cancer symposium, and if folks were there, you would see it was standing room only, several layers back. And part of that, and a good deal of that, is the data is now maturing. In different disease sites, it takes time to mature. Prostate cancer, breast cancer, sometimes it takes up to 10 years for clinician to feel confident.

I think what was partly reflected in that prostate cancer symposium was a changing of minds, where folks who were somewhat reticent to adopt newer technologies for what they previously may have thought of as dangerous treatment, are now feeling compelled. And in fact, if they're not utilizing such treatment, they may be at a disadvantage and not treating their patients appropriately. And in general, we're seeing that in other disease states as well. And so what I am receiving as somebody who's treated on numerous different platforms and now has joined Accuray, what I'm seeing is unbridled interest in our company. And so from a company perspective, it's, it's invigorating and exciting, and I know all of us have been, spread quite thin, fielding a lot of different, interested colleagues and, and clinicians who want to learn more about Accuray. I'll let you guys, chime in.

Sean Collins
Director of CyberKnife Prostate Program, MedStar Georgetown University Hospital

I think you summarized it perfectly. Do you guys have anything to add?

Jon Lischalk
Medical Director of the NYC CyberKnife and Director of Research for the Department of Radiation Oncology, NYU Long Island School of Medicine

I would echo everything, Seth just said. You know, I've been seeing Dr. Collins, you know, treat prostate SBRT for-

Sean Collins
Director of CyberKnife Prostate Program, MedStar Georgetown University Hospital

17

Jon Lischalk
Medical Director of the NYC CyberKnife and Director of Research for the Department of Radiation Oncology, NYU Long Island School of Medicine

...17 years. But it's just amazing to see. The data is the key. I mean, Seth's absolutely right, and the data. It just seems like the dominoes have fallen for almost every disease site. You know, for years, it was - you were probably a pariah talking about SBRT for lung cancer, if you were in a group of - with surgeons and prostate cancer as well. Now we're seeing it with oligometastatic disease. I think the next frontier is gonna be breast cancer. We've seen it in CNS. So I mean, the data is the data, and you can't really argue with it. And, you know, I think when you're looking at people that have different machines, probably mimicry is flattering.

You know, I see people trying to reinvent the wheel with Synchrony or, you know, IGRT, and it's like: Well, we already have this figured out. Why are we trying to, like, do the same thing on some other, you know, platform? So, you know, that's how I feel.

Nima Aghdam
Instructor of Radiation Oncology, Harvard Medical School, Beth Israel Deaconess Medical Center

I have a simple philosophy: Where prostate goes, radiation oncology goes. And this week, we confirmed that what Sean has been doing, what Jon has been doing, and what I've been doing with prostate cancer is the right thing to do for our patients. The platform that CyberKnife provides its users is easy to use. It's user-friendly, has a strong community of physicians with deep bench of clinicians and scientists who can support your adoption of the technology. If we are moving towards an era of five-fraction prostate, you want this device to not just treat prostate, and as we illustrated, it is excellent at treating CNS. That was its birthplace. It's excellent at treating polymetastatic, oligometastatic disease, and it's excellent actually in treating upper GI. It actually has tremendous value in that.

I think that people are slowly recognizing that Accuray users, CyberKnife users, adopted this technology early on. They were pariahs at the time, but now they are the source of knowledge, and Sean has informed my career and Jon's career with his expertise, and we will continue to advocate for that. And perhaps you can see, you know, our-

... our group goes from Georgetown to NYU, to Harvard Medical School, to UNC, and we are spreading. And we are not merely evangelists because, you know, we don't need to evangelize. The truth is there in the details of the device. We use it every day, and we know how our patients do. So I think that all you have to do is listen to our patients, and you'll see the value.

Connie Mantz
Chief Physician Executive, 21st Century Oncology

Yeah. And one more comment to add maybe is that, you know, in addition to all the, you know, excellent technical attributes of, of, you know, Radixact and CyberKnife system, you know, Accuray enjoys a tremendous brand advantage with CyberKnife. And, you know, when patients come, the name CyberKnife in the patient base means stereotactic therapy. It's 30 years on, plus since the company launched CyberKnife, and patients come in asking for that brand, you know, as the surrogate for the technology of stereotactic therapy. And that's huge, you know. And then you layer on top of that some of the technical improvements in terms of tracking and gating and so forth, and as described here by the other speakers.

And Radixact is offering, as already mentioned a few times, solutions for adaptive radiotherapy, which looks as though it's coming onto the horizon in terms of efficient throughput and application. And the data are beginning to accrue to the benefit of adaptive radiotherapy for certain disease sites. And so, you know, so at least from my perspective as a buyer of equipment and having to deal with a large number of physicians in the network that are making demands that are technical in nature, the company provides a set of platforms that look to be ideally suited for near future.

Elizabeth Kennard
VP of Global Marketing, Accuray

Thank you so much. Thank you for all of the questions. Thank you to our management team and our esteemed thought leaders for lending your thoughts. We appreciate that. And now I'd like to turn this back over to Suzanne for closing remarks.

Suzanne Winter
CEO, Accuray

Thank you. I'll have you all sit. Thank you. It's a great question, Marie. You know, and I think that, you know, that is, that is sort of the our challenge, you know, in moving forward. But I think what you're hearing here is, there are a number of things that are growth catalysts that are really coming to bear. One, I think we can we've established that these are large growing markets, you know, and a tremendous opportunity in the emerging markets. And this is a market that we really haven't participated in fully compared to maybe the two other competitors in this space. So we think we have a tremendous opportunity there just to even double the total applicable market.

You know, we're looking to grow faster than the market, and we're gonna continue to innovate in product innovation, and that's converging with clinical trends that also we're well-positioned to take advantage, and it's also positioned for changes in reimbursement. You heard it. The reimbursement has been a barrier. You know, folks have sort of held off because this is gonna be a challenge for them to manage the revenue, but I think the handwriting is on the wall. It's moving forward. ASTRO has come up with this model so that there is equity between, you know, 5-fraction treatments versus 40-fraction treatments. So there's a number of things that are moving us forward and... Then the clinical data.

Again, these are clinical trials that sometimes take five, 10 years to be able to see how precision has an impact on quality of life, and all of that is moving in the right direction. At the same time, Sandeep's team has to, this is, you know, this is going out there and making sure that we're doing everything possible to invest in our commercial teams, to invest in clinical education, because confidence for physicians in starting to do, you know, higher powered, fewer fractions is gonna be incredibly important. And so all of, you know, all of our clinician partners in this effort is gonna be paramount. You know, significant growth opportunities for us in solutions and service.

Again, we have mainly focused on service contract, break, fix, and now as we focus on installing, growing our installed base, and the ability to provide solutions that, you know, our customers are looking for over this course of 10-15 years, we think will be positive for the top line, but also positive, for the bottom line as well. And then we will continue as a company to just, you know, build our own organic growth and operations so that we're putting ourselves in the best position to be able to look at other things that may be more strategic, that we might be able to add, to our growth, engine. So again, we are about, you know, creating meaningful value for all of our stakeholders, really by continuing to figure out what are those gaps and closing those gaps to cancer care.

I want to thank our guest speakers. That was wonderful, as well as our management, and I appreciate everybody's engagement today in our session. Well, we will talk to you again at our earnings call on November first. Thank you very much.

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